MX2018004021A - Stable formulations of fingolimod. - Google Patents
Stable formulations of fingolimod.Info
- Publication number
- MX2018004021A MX2018004021A MX2018004021A MX2018004021A MX2018004021A MX 2018004021 A MX2018004021 A MX 2018004021A MX 2018004021 A MX2018004021 A MX 2018004021A MX 2018004021 A MX2018004021 A MX 2018004021A MX 2018004021 A MX2018004021 A MX 2018004021A
- Authority
- MX
- Mexico
- Prior art keywords
- water
- fingolimod
- filler
- examples
- insoluble
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 5
- 229960000556 fingolimod Drugs 0.000 title abstract 3
- 238000009472 formulation Methods 0.000 title abstract 2
- KKGQTZUTZRNORY-UHFFFAOYSA-N fingolimod Chemical compound CCCCCCCCC1=CC=C(CCC(N)(CO)CO)C=C1 KKGQTZUTZRNORY-UHFFFAOYSA-N 0.000 title 1
- 239000000945 filler Substances 0.000 abstract 7
- SWZTYAVBMYWFGS-UHFFFAOYSA-N fingolimod hydrochloride Chemical compound Cl.CCCCCCCCC1=CC=C(CCC(N)(CO)CO)C=C1 SWZTYAVBMYWFGS-UHFFFAOYSA-N 0.000 abstract 3
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Natural products NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 abstract 1
- 239000004471 Glycine Substances 0.000 abstract 1
- XAAHAAMILDNBPS-UHFFFAOYSA-L calcium hydrogenphosphate dihydrate Chemical group O.O.[Ca+2].OP([O-])([O-])=O XAAHAAMILDNBPS-UHFFFAOYSA-L 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 150000002148 esters Chemical class 0.000 abstract 1
- 229960004967 fingolimod hydrochloride Drugs 0.000 abstract 1
- 125000003630 glycyl group Chemical group [H]N([H])C([H])([H])C(*)=O 0.000 abstract 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 150000005846 sugar alcohols Chemical class 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/485—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Emergency Medicine (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Sugar alcohol-free formulations of fingolimod. Compositions of fingolimod, salts thereof, or esters thereof that lack sugar alcohols are disclosed. The composition may include a water- soluble filler and a water-insoluble filler, in addition to other common excipients. In some examples, the water-soluble filler is glycine and the water-insoluble filler is dibasic calcium phosphate dihydrate as fillers. In some examples, the water-soluble filler and water-insoluble filler are present in equal concentrations. The compositions disclosed here may be used to make immediate release dosage forms containing fingolimod hydrochloride.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562236373P | 2015-10-02 | 2015-10-02 | |
| PCT/US2016/046002 WO2017058364A1 (en) | 2015-10-02 | 2016-08-08 | Stable formulations of fingolimod |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2018004021A true MX2018004021A (en) | 2018-09-11 |
Family
ID=58427788
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2018004021A MX2018004021A (en) | 2015-10-02 | 2016-08-08 | Stable formulations of fingolimod. |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US20180280322A1 (en) |
| EP (1) | EP3355863A4 (en) |
| AU (1) | AU2016331648A1 (en) |
| BR (1) | BR112018006648A2 (en) |
| CA (1) | CA3000186A1 (en) |
| IL (1) | IL258420A (en) |
| MX (1) | MX2018004021A (en) |
| WO (1) | WO2017058364A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GR1009654B (en) * | 2018-08-31 | 2019-11-18 | Φαρματεν Α.Β.Ε.Ε. | Pharmaceutical composition comprising an immunomodulatory agent and method for the preparation thereof |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL2465492T3 (en) * | 2007-10-12 | 2015-11-30 | Novartis Ag | Compositions comprising sphingosine I phosphate (sip) receptor modulators |
| US20130095177A1 (en) * | 2010-04-22 | 2013-04-18 | Ratiopharm Gmbh | Method of preparing an oral dosage form comprising fingolimod |
| US20140199382A1 (en) * | 2013-01-11 | 2014-07-17 | Cadila Healthcare Limited | Stable pharmaceutical compositions of an s1p receptor agonist |
| US20160128951A1 (en) * | 2013-07-29 | 2016-05-12 | Aizant Drug Research Solutions Pvt Ltd | Pharmaceutical compositions of fingolimod |
| WO2015104666A2 (en) * | 2014-01-09 | 2015-07-16 | Torrent Pharmaceuticals Limited | Pharmaceutical composition of fingolimod |
-
2016
- 2016-08-08 CA CA3000186A patent/CA3000186A1/en not_active Abandoned
- 2016-08-08 US US15/764,169 patent/US20180280322A1/en not_active Abandoned
- 2016-08-08 AU AU2016331648A patent/AU2016331648A1/en not_active Abandoned
- 2016-08-08 EP EP16852244.9A patent/EP3355863A4/en not_active Withdrawn
- 2016-08-08 BR BR112018006648-6A patent/BR112018006648A2/en not_active Application Discontinuation
- 2016-08-08 MX MX2018004021A patent/MX2018004021A/en unknown
- 2016-08-08 WO PCT/US2016/046002 patent/WO2017058364A1/en not_active Ceased
-
2018
- 2018-03-28 IL IL258420A patent/IL258420A/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| AU2016331648A1 (en) | 2018-05-17 |
| CA3000186A1 (en) | 2017-04-06 |
| EP3355863A4 (en) | 2019-06-19 |
| IL258420A (en) | 2018-05-31 |
| BR112018006648A2 (en) | 2018-10-23 |
| WO2017058364A1 (en) | 2017-04-06 |
| EP3355863A1 (en) | 2018-08-08 |
| US20180280322A1 (en) | 2018-10-04 |
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